FDA hits Olympus with warning letters after factory inspections The FDA today released warning letters against Olympus Medical Systems Corp. and Olympus Corp. subsidiary Aizu Olympus following inspections of their endoscope and reprocessor manufacturing facilities.To get more news about https://seesemborescopes.com/ Industrial Videoscope, you can visit seesemborescopes.com official website. The warning letters allege medical device reporting (MDR) and quality system violations at the manufacturing operations. “Olympus’ highest priority is providing patients and users with safe and effective medical devices that comply with all applicable legal and regulatory requirements,” the company said in a statement to Medical Design & Outsourcing. “For that reason, we are committed to working together with FDA to address concerns.” FDA issued the first letter to Aizu Olympus President and CEO Yasuo Takeuchi on Nov. 2, 2022, following a July 5–8 inspection. The warning letter covers the company’s endoscope and automated reprocessing equipment manufacturing operations in Aizuwakamatsu, Fukushima, Japan. FDA issued the second letter to Olympus Medical Systems President Tomohisa Sakurai on Dec. 12, 2022, following a Sept. 6-9 inspection. That warning letter covers the company’s gastrointestinal and surgical endoscope manufacturing operations in Hachioji-shi, Tokyo, Japan. FDA Center for Devices and Radiological Health (CDRH) Director Dr. Jeff Shuren said the agency and Olympus have “extensive and ongoing efforts” to address compliance issues related to the reprocessing of endoscopes. “However, as described in the recent warning letters, Olympus is not in compliance with MDR reporting and quality system requirements,” Shuren said in a statement. “During recent inspections, CDRH determined that Olympus did not meet requirements to assure the quality and performance of the devices such as adequate testing and documentation of the device assembly process. In addition, Olympus did not develop MDR procedures, and did not submit MDRs within the required timeframes.” More about the warning letter Olympus makes, among many other products, surgical and gastrointestinal endoscopes and automated endoscope reprocessors. Endoscopes can be reused if appropriately cleaned and disinfected or sterilized to remove bacteria that could cause harmful or even fatal infections. In its warning letter to Olympus Medical Systems, the FDA said the manufacturer conducted a device recall after receiving complaints that its uretero-reno fiberscope and uretero-reno videoscope malfunctioned while in use, but failed to notify the FDA as required by law. According to the FDA, Olympus responded with a promise to improve its MDR reporting process and train staff. The FDA said it could not determine the adequacy of that ongoing effort until its conclusion.

Who Is Driving The Industrial Videoscope Market Giants To Spend More By 2027? The detailed analysis of “Industrial Videoscope market Size 2022” that offers latest insights for business professionals. Using BI tools such as Factiva and Hoover, the report offers a complete analysis and is a mix of market intelligence studies and industry insights. Ready by a panel of highly qualified market analysts and consultants, the report is spread across “133” pages offering chapter wise detailed market analysis that enables the clients with multiple data points and encourages them to have a 360-degree overview of the market performance.To get more news about https://seesemborescopes.com/es/products/2-0-mm-probe video borescope, you can visit seesemborescopes.com official website. The Industrial Videoscope report also delivers a detailed analysis for market scenarios throughout the forecast period and offers actionable insights on the performance factors. The report offers a detailed view for the numerical facts and graphical analysis to determine insightful data for past and present market trends. The global Industrial Videoscope market was valued at 2473.91 Million USD in 2021 and will grow with a CAGR of 12.93% from 2021 to 2027, based on HNY Research newly published report.The prime objective of this report is to provide the insights on the post COVID-19 impact which will help market players in this field evaluate their business approaches. Also, this report covers market segmentation by major market verdors, types, applications/end users and geography(North America, East Asia, Europe, South Asia, Southeast Asia, Middle East, Africa, Oceania, South America).A videoscope is a flexible inspection instrument that consists of a flexible insertion tube with a video display at one end and an objective lens at the other. The image is produced using a CCD camera chip 1/10th inch or smaller in diameter. The image is relayed from the inspection area to the video display electronically. An internal fiber optic light guide, or LED lighting at the objective, is used to illuminate the area being inspected. Industrial videoscopes are used for inspection of areas that are difficult or impossible to view without dis assembly or destruction of the item to be inspected.The United States leads in Industrial Videoscope Industry The United States leads in Industrial Videoscope spend. Large gains in Aerospace spend in China, with 15% growth year-over-year, respectively, were a key driver of the growth in Transport and automotive technology. China are high-growth markets, due to increasing Building and construction industry and automotive industry Russia`s huge growth opportunities As the continued development of Russia`s oil and chemical industry, Russia provides Industrial Videoscope companies with strong growth opportunities for future growth. The average price will fall further The product average price declined in the past few years due to the technology development, the average price will keep this trend in the few future years due to increasing mature manufacturing technology and lowing cost of raw materials. Strong market competition is resulting in annual 2 percent price erosion. Technology development trend Improved Measurement Capabilities Certain applications require a videoscope that can make accurate measurements. Tried-and-true stereo measurement provides depth, area, distance, and point-to-line measurements. The involved technique of one-to-one matching, where an optical tip adaptor is paired with a single scope on a specialized jig, has expanded the capabilities of stereo measurement and increased precision. Previously, stereo measurement required operators to position the distal end of the insertion tube very close to the crack or defect. Now, stereo measurement can be performed from twice the distance as was possible with previous-generation videoscopes, covering an inspection area four times larger. This means that a 1.5-inch flaw can be measured from one inch away. Operators can expect to spend less time navigating and positioning the distal end for a stereo measurement. Features that Support Evaluation Features that support an inspector`s work are available to help get answers. Simple videoscopes that only record images are popular, but mid-range and high-end videoscopes have clever features that aid operators in evaluating flaws.